The autoimmune diseases are a reality for a significant portion of the world population. There are several types, which can cause different complications.
People who suffer from these disorders often need continuous treatment for life, considering that many of these pathologies have no cure – although they can have their symptoms controlled.
The drug Stelara is generally administered to patients undergoing treatment for psoriasis or psoriatic arthritis. Two disorders that fall into the category of autoimmune diseases and that need continuous treatment
- 1 What is the medicine Stelara?
- 2 What is the medicine Stelara for?
- 3 How does the active ingredient Ustequinumab work?
- 4 As the package insert indicates to use Stelara: application
- 5 What is the dosage according to the package leaflet?
- 6 What are the side effects of Stelara?
- 7 Value: what is the price of Stelara and where to buy cheaper?
- 8 Ustequinumabe tem no SUS?
- 9 Is it approved by ANVISA?
- 10 How to budget Stelara?
What is the medicine Stelara?
Stelara is the trade name of a biological medicine produced by the Janssen-Cilag laboratory. It is a completely human monoclonal antibody and its active ingredient is Ustequinumab – a substance that acts on the immune system.
This medication is sold in an injectable version, for subcutaneous administration (under the skin) and, in general, it is indicated for the treatment of patients suffering from psoriasis and psoriatic arthritis (two autoimmune diseases ).
Psoriasis is a chronic skin disorder and among its causes are issues related to the immune system, interactions with the environment and genetic susceptibility.
Arthritis, a well-known disease, is a problem that causes inflammation in the joints. The difference is that psoriatic arthritis is an inflammatory condition that affects both the skin and the joints.
What is the medicine Stelara for?
According to the package leaflet, the drug Stelara is indicated for the treatment of plaque psoriasis (the most common type, in which dry, reddish flaking plaques are formed), moderate to severe.
Treatment should be performed only in adults who have not responded, are contraindicated or who are intolerant to other systemic therapies – such as cyclosporine, methotrexate or ultraviolet A radiation associated with the use of psoralen (PUVA).
In addition, this medication alone or in combination with methotrexate may also be indicated for the treatment of active psoriatic arthritis in adult patients. This can occur when the person has an insufficient or inadequate response to treatment with disease-modifying antirheumatic drugs (DMARD).
Is Stelara used to treat Crohn’s disease?
There are no indications for use in the Stelara package insert in cases of Crohn’s disease . However, there are studies that attest to the effectiveness of the use of this medication in some cases of the disease.
These researches show that Stelara stops inflammation at a different point in the immune response. In addition, they demonstrate that the majority of people who have taken Ustequinumab (active ingredient), have had a satisfactory response.
That is, they maintained a response to treatment and presented remission of the disease (when it becomes asymptomatic) for up to two years. Finally, some studies have also attested that there was a rapid response to the drug – that is, a significant decrease in symptoms in a short period of time.
Despite this, as mentioned, the manufacturer does not indicate the use for this case. Therefore, pay attention to the suggestions and indications of the medical team responsible for your case.
How does the active ingredient Ustequinumab work?
Ustequinumab (active ingredient of Stelara) is a human monoclonal antibody (medicines of biological origin that act with high precision in the body) that specifically binds to human cytokines interleukin (IL) -12 and IL-23.
This drug inhibits the bioactivity of human IL-12 and IL-23 and thus prevents connectivity with the protein receptor on the surface of immune cells.
From its action in the body, Ustequinumab can exert clinical effects in both psoriasis and psoriatic arthritis by interrupting the cytokine pathways (a type of protein) related to Th1 and Th17 (auxiliary cells), which are central to pathophysiology of these diseases.
As the package insert indicates to use Stelara: application
The medicine Stelara is available in an injectable version, for subcutaneous application (under the skin).
Its administration should take place in a hospital environment under medical supervision. However, it can be self-applied if the doctor considers it appropriate – after adequate training.
In the following topics you can check the preparation of the injection and how to perform its application:
The package insert provides practical instructions on how to prepare Stelara’s syringe. Check out:
- Remove the syringe from the refrigerator;
- Check if the correct dosage and also the expiration date;
- Prepare the material that will be needed for the application (alcohol swab, cotton ball or gauze and container for disposing of syringes);
- Check the solution inside the syringe – keep the syringe filled with the covered needle pointing upwards and make sure it is not damaged. See if the liquid is clear to slightly translucent and colorless (slightly yellow).
In addition, there are recommendations that the product should not be used if it is frozen, colored differently from the original, cloudy or with large particles. Also, you should not remove the needle cap from the filled syringe.
Preparation of the application site
First, it is necessary to choose the injection site. The Stelara package insert recommends that it be applied to the upper thigh or belly (about 5cm below the navel).
In cases of psoriasis treatment, it is recommended to avoid the affected areas. In addition, if the application is carried out by someone else, it can be done on the upper arm as well.
To prepare the place, just wash your hands thoroughly with soap and warm water. Then, apply an alcohol swab to the injection site and do not touch this area before application.
There is detailed information on the package insert on how to apply the Stelara injection, it includes – including – illustrations to facilitate the procedure.
Despite this, it is important to emphasize that this should never be done without authorization from the medical team and without receiving specific training.
In general, the application is carried out as follows:
- Remove the needle cap (when you are ready to inject) and do not touch it or let it touch anything;
- Hold a fold of skin with your thumb and index finger (without squeezing) and insert the needle;
- Keep the skin fold between your fingers and push the plunger * with your thumb until the end, slowly and evenly (in order to inject the product);
- When the plunger reaches the end of the syringe body and all the medicine has been injected, you must loosen the skin fold and gently remove the needle.
* Plunger is the cylinder or disc that moves in and out of syringes.
Once the application has been completed, simply discard the syringe in an appropriate container (syringes should never be reused ).
There may be a small amount of blood or liquid left at the injection site, which is normal. Then, press a cotton ball or gauze over the spot and press for 10 seconds – do not rub.
What is the dosage according to the package leaflet?
According to the package insert, in general the recommended dose of Stelara is 45mg, which should be administered at weeks 0 and 4. Then, the application is every 12 weeks.
In patients weighing more than 100kg, the 90mg dose can be indicated, following the same time intervals.
In addition, there is a recommendation that interruption should be considered if the patient does not respond by week 28 of treatment.
Finally, the package insert indicates that in some situations the dose can be adjusted: for patients who respond inadequately to the 45mg dose (every 12 weeks), the doctor can change the dose to 90mg.
Another case in which there may be changes is for patients who respond inadequately to 90mg (every 12 weeks). The medical team may decide to decrease the dose range from 12 to 8 weeks.
What are the side effects of Stelara?
Any medication has possible side effects, which may or may not manifest itself in patients who use it.
In the case of Stelara, the bull divides into two main groups. Check, first, the common adverse reactions (affect 1% to 10% of patients):
- Infections and infestations of the upper respiratory tract, nasopharyngitis;
- Dizziness, headache;
- Pain in the oropharynx (small space in the oral cavity between the root of the tongue, the soft palate and the epiglottis);
- Diarrhea, nausea, vomiting;
- Itching (itching);
- Low back pain, muscle or joint pain;
- Fatigue, redness or pain at the application site.
There is also an emphasis on unusual reactions (occurring in a maximum of 1% of patients):
- Dental infections;
- Viral infection of the upper respiratory tract;
- Vulvovaginal mycotic infection (mycosis);
- Nasal congestion;
- Reactions at the application site – such as bleeding, hematoma, infiltration, swelling and itching;
- Asthenia (decreased physical strength).
For more information about possible side effects of Stelara, seek medical advice and read the package leaflet .
Value: what is the price of Stelara and where to buy cheaper?
The price * of the drug Stelara varies according to its milligram and commercial version, in addition to availability and also according to your region.
But, to know where to buy the medicine at the best price in your locality, you can access the website Consulta Remédios . It allows a price comparison of the same medicine in different establishments, so it is possible to choose the best one for you.
Check out the different versions of Stelara and the values:
- Stelara (45mg) with 1 ampoule containing 0.5mL of solution for subcutaneous use – the price varies between R $ 14,250 and R $ 17,400;
- Stelara (45mg) with 1 filled syringe (with safety device) containing 0.5mL of solution for subcutaneous use – the price varies between R $ 14,300 and R $ 16,100;
- Stelara (90mg) box with 1 filled syringe (with safety device) containing 1mL of solution for subcutaneous use – the price varies between R $ 30,000 and R $ 35,000;
- Stelara (130mg) box with 1 ampoule containing 26mL of solution for intravenous use – the price varies between R $ 37,600 and can reach almost R $ 50,000.
* Prices consulted in March 2020. Prices may change.
Are you generic or similar?
No . The medicine Stelara is of the Biological type and, therefore, does not have generic or similar versions. These medications are generally created for the treatment of very specific diseases or as alternative forms of treatment.
Therefore, if another version of this medicine is created, it will also be classified as being of the biological type.
Ustequinumabe tem no SUS?
-Yeah . The substance Ustequinumab (active ingredient of Stelara) is present in the List of Essential Medicines (RENAME) of 2020. Therefore, it must be provided by the Unified Health System (SUS).
It is worth emphasizing that, in all cases, it is only possible to have access to the medicine with a medical prescription.
Is it approved by ANVISA?
-Yeah . The drug Stelara is regulated by ANVISA (National Health Surveillance Agency) and has Registration No. 112363394.
Therefore, it is approved and marketed with proven efficacy and safety. In addition, it is in the therapeutic class of immunosuppressants and, as we have seen, it is a medication categorized as Biological.
How to budget Stelara?
If a medication is not available via the Unified Health System (SUS), patients with a medical prescription can still make a court application to receive treatment funded by the Federal Government or Health Plan – if applicable.
In these circumstances, it is necessary to open a process following the requests previously stipulated. Among them is the delivery of documents that include, among others:
- Medical report;
- Standard requirement;
- Budget of 3 pharmacies .
You can count on legal counseling to purchase medicines to help with the budgeting process. This advisory provides a personalized quote and in an easy way.
When accessing the link , make your registration informing some personal data and the medicine in question. Then, click on “request quotes” and wait for the return.
Stelara is a very important medicine to maintain the quality of life of many people who suffer from psoriasis or psoriatic arthritis. Just like many other remedies that work in the treatment of autoimmune diseases.
If you want to know more information about medicines, access the ” Remedies ” tab . Keep following the Healthy Minute for more information on health and well-being!